A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT07581002
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pivekimab Sunirine — DRUG
    Intravenous
  • Venetoclax — DRUG
    Orally
  • Azacitidine — DRUG
    Intravenous Or Subcutaneous
  • Matching Placebo for PVEK — DRUG
    Intravenous

Study Details

Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy. Pivekimab sunirine is a drug being evaluated in the treatment of AML.This is a Phase 2/Phase 3, study of PVEK. Phase 2 is open-label and randomized. Phase 3 is double-blind, randomized. Phase 2 and Phase 3 studies test potential new treatments in patients with a condition or disease. Open-label means that both patients and study doctors know which study treatment is given to patients in Phase 2 of the study. Double-blind means that neither the patients nor the study doctors know who is given which study treatment in Phase 3 of the study. Approximately 660 adult participants will be enrolled in 180 sites worldwide. In Phase 2 of the study, patients will be randomized to receive PVEK + VEN + AZA or standard of care treatment with VEN + AZA. In Phase 3, patients will be randomized to receive PVEK + VEN + AZA or a matching-placebo for PVEK plus VEN + AZA. PVEK is given as an infusion into the vein, AZA is given as an injection under your skin (subcutaneous) or as an infusion into the vein (intravenous) (depending on country where patient enrolls), and VEN is a tablet given by mouth. The total study duration is approximately 71 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Key Dates

First listed
May 12, 2026
Start date
Jun 30, 2026
Status verified
Aug 2026
Primary completion
May 31, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2: Arm A - PVEK, VEN, and AZA
    Participants will receive PVEK, VEN, and AZA
  • Active Comparator: Phase 2: Arm B - VEN and AZA
    Participants will receive VEN and AZA
  • Experimental: Phase 3: Arm A - PVEK, VEN, and AZA
    Participants will receive PVEK, VEN, and AZA
  • Experimental: Phase 3: Arm B - PVEK-Placebo, VEN, and AZA
    Participants will receive PVEK-Placebo, VEN, and AZA

Primary Outcome Measure

Phase 2: Complete remission (CR) [ Time Frame: Up to Approximately 71 Months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 279568DuarteCalifornia91010-
Moffitt Cancer Center /ID# 279192TampaFlorida33612-
Montefiore Medical Center - Moses Campus /ID# 279399The BronxNew York10467-

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By research site
City of Hope National Medical Center· Duarte, CAMoffitt Cancer Center· Tampa, FLMontefiore Medical Center - Moses Campus· The Bronx, NY

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